The present invention relates to isolated rooms and/or equipment for maintaining an aseptic environment, and in particular, to a system for transferring sterile objects into such an isolated space.
In the past, the production and handling of certain products, such as pharmaceuticals, was carried out in a clean room in order to avoid contamination of the product during processing. The clean room was maintained as an isolated, aseptic area and equipment or other objects entering the isolated area, such as consumables used during the processing of such products, had to be sterilized prior to being introduced into the aseptic environment. Additionally, personnel working in such rooms were required to wear protective clothing to prevent contamination of the area.
Recently, in order to reduce the expenses associated with operating a clean room, barrier-isolated equipment has been introduced which maintains a local aseptic environment directly around processing equipment for certain types of products. The equipment is accessed through glove portals and objects are sterilized and transferred into the isolated area via air locks. The objects being introduced into the isolated area can be presterilized or are sterilized within the air lock prior to being introduced into the barrier isolated area. Generally, each machine or isolated area would require an air lock or treatment vessel which receives the articles to be sterilized, such as closure elements for pharmaceutical containers. The closure elements are then sterilized within the treatment vessel prior to being passed into the isolated system.
It would be desirable to reduce the time required and cost involved for sterilizing parts or other materials which are to be introduced into an isolated system on site.
One solution to this problem, which is described in U.S. Pat. No. 5,447,699, which was jointly invented by the present inventor and is assigned to the assignee of the present invention, provides a combination container for holding sterilized elements such as vial stoppers and a sterilizable transfer port for transferring the sterilized elements into the isolation system. However, exposed areas of the transfer port components must still be sterilized on site prior to the transfer of elements into the isolation system. This arrangement allows the required elements to be sterilized at a different location prior to shipping to the processing and packaging company where the sterilized elements are fed into the isolation system, such as a system for bottling pharmaceuticals.